Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a…
Medical device recall Z-0801-2016. Published in FDA’s Enforcement Report on Mar 2, 2016.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 2, 2016. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 1515 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
1515, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
RPN/Catalog number: C-NPMS-501J-15 C-NPMSY-501J-15 C-PMS-300-FA C-PMS-300J-FA C-PMS-301-FA C-PMS-301J-FA C-PMS-400-FA C-PMS-401-FA C-PMS-401J-FA C-PMSY-300-FA C-PMSY-300J-FA C-PMSY-400J-FA C-PMSY-401-FA Lots: 6054830 6054831 6072436…
Every code shown here, 1,300 characters
RPN/Catalog number: C-NPMS-501J-15 C-NPMSY-501J-15 C-PMS-300-FA C-PMS-300J-FA C-PMS-301-FA C-PMS-301J-FA C-PMS-400-FA C-PMS-401-FA C-PMS-401J-FA C-PMSY-300-FA C-PMSY-300J-FA C-PMSY-400J-FA C-PMSY-401-FA Lots: 6054830 6054831 6072436 6078670 6081720 6083977 NS6054841 NS6054842 NS6075552 NS6082372 NS6082373 NS5833881 NS5881267 NS5881268 NS5892106 NS5892107 NS5892108 NS5914766 NS5922706 NS5928596 NS5932820 NS5932821 NS5967447 NS5967448 NS5967449 NS6014474 NS6014475 NS6014484 NS6014485 NS6042778 NS6042795 NS6042796 NS6050046 NS6063330 NS6063354 NS6075555 NS6100599 NS6100600 NS6108225 NS6124985 NS5888542 NS5928597 NS6028553 NS6042797 NS6090273 NS6090274 NS6100601 NS6130149 5800570 5860387 5891906 5980254 6003160 6062725 6143835 NS5830771 NS5866956 NS5866957 NS5881269 NS6014460 NS6042798 NS6050047 NS6075534 NS6075556 5895598 6129058 6148613 NS5932822 NS5932837 NS5994907 NS6130498 6067782 6139280 NS6042805 NS6130500 6049951 6137353 6139281 6034986 6049957 6067784 NS5833887 NS5866959 NS5881272 NS5881334 NS5881335 NS5919925 NS6047449 NS6054847 NS6054848 NS6072526 NS6072555 NS6082379 NS6090277 NS6105921 NS6124989 NS6130501 NS6148639 NS5866961 NS5866962 NS5892115 NS5922709 NS5932844 NS5974256 NS6031988 NS6031990 NS6042578 NS6050052 NS6050053 NS6031992 NS6031993 NS6130504 NS6137424 NS6054849
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada
The states and territories these words name
- District of Columbia
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 6, 2016.
- FDA classified it on Feb 24, 2016.
- FDA’s Enforcement Report published it on Mar 2, 2016.
- FDA terminated it on Aug 23, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cook Inc., of Bloomington, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.